HENKEL CAPITAL S.A. DE C.V.
⚠️ Moderate Risk
FEI: 3003208006 • Zapopan, Jalisco • MEXICO
FEI Number
3003208006
Location
Zapopan, Jalisco
Country
MEXICOAddress
Calle Pedro Martinez Rivas No 746, Parque Industrial Belenes Norte, Zapopan, Zapopan, Jalisco, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2005 | 53FD99OTHER HAIR COLORING PREPARATIONS, N.E.C. | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 12/5/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 8/23/2005 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is HENKEL CAPITAL S.A. DE C.V.'s FDA import refusal history?
HENKEL CAPITAL S.A. DE C.V. (FEI: 3003208006) has 3 FDA import refusal record(s) in our database, spanning from 8/23/2005 to 12/5/2005.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. HENKEL CAPITAL S.A. DE C.V.'s FEI number is 3003208006.
What types of violations has HENKEL CAPITAL S.A. DE C.V. received?
HENKEL CAPITAL S.A. DE C.V. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about HENKEL CAPITAL S.A. DE C.V. come from?
All FDA import refusal data for HENKEL CAPITAL S.A. DE C.V. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.